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RECRUITING
NCT05778734
NA

StuDy AimED at Increasing AlCohol AbsTinEnce

Sponsor: University of Illinois at Chicago

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the feasibility \& acceptability of an integrated CM-PST intervention (in K99 phase) and preliminary efficacy (in R00 phase), vs. CM alone, to improve treatment efficacy and inform about neural mechanisms of treatment effects in young adults with Alcohol Use Disorder (AUD). The aims are as follows: K99 Aim: Test feasibility \& acceptability of a developed CM-PST, by meeting these benchmarks: 2a Feasibility: enroll 20 participants in the new CM-PST in a single-arm pre- and post-study, and retain ≥85% at wk 12. 2b Deliver CM-PST at ≥90% fidelity to intervention protocol. 2c Acceptability to participants: Achieve mean score ≥3 on Client Satisfaction Scale Questionnaire and satisfaction from semi-structured interviews. R00 Aim 1) Test preliminary efficacy of CM-PST in a 2-arm pilot RCT: Male/female young adults (aged18-24) who meet AUD criteria will be randomized to CM-PST or CM-only control, and assessed at baseline (0), 3, and 6 months. Primary study endpoint will be 3 months. R00 Aim 2 (Exploratory) Explore potential neural mechanisms of CM-PST effects, by fMRI scanning \& analyses of core regions of the brain circuits regulating positive affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex), and connectivity between these core regions.

Official title: StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)

Key Details

Gender

All

Age Range

18 Years - 24 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2023-07-30

Completion Date

2028-05-31

Last Updated

2025-04-03

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

CM-PST

CM-PST is a tailored behavioral intervention that enables young adults with AUD to successfully manage and overcome everyday life challenges influencing their alcohol intake.

BEHAVIORAL

CM only

CM is a behavior therapy that rewards individuals for evidence of positive change (alcohol abstinence).

Locations (1)

University of Illinois at Chicago

Chicago, Illinois, United States